Pfizer Inc and BioNTech could secure emergency US and European authorization for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said on Wednesday.
“If all goes well, I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively,” Ugur Sahin said.
Sahin told CNN that the firms will seek emergency approval from US on Friday itself. He expressed hope that the coronavirus may be brought under control by the middle of 2021, if everything goes according to the companies’ plans.
“Depending on how fast this [review] is really accomplished, we might get an authorization, or conditional approval already in 2020 which might help us start distribution of the first vaccine batches already in 2020,” Sahin said.
There have been no serious side effects among the 41,135 adults who received two doses, the companies said in a joint statement. The most common reactions were that 3.7 percent of participants experiencing fatigue and 2 percent had a headache, it added.
The study reached 170 confirmed cases of COVID-19, with the vaccine candidate BNT162b2 demonstrating 95 per cent efficacy beginning 28 days after the first dose, Pfizer said.
